• Formulation Risk Assessment & Scale-Up Support (FD/DQA Interface)
• QRA Technical Evaluation: Technical review and evaluation of Quality Risk Assessment (QRA) reports for current formulation projects as well as major product/process changes. Ensure all potential product quality and process risks are identified early in the development lifecycle.
• CPP & CQA Tracking: Critically track the controls proposed in QRA reports. Ensure that Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) for all dosage forms are adequately addressed and mitigated prior to scale-up and tech transfer.
• FD Collaboration: Act as the primary DQA link for the Formulation Development (FD) team to ensure QbD (Quality by Design) principles are embedded into early-stage development.
• Document Review for Quality Management System (QMS)
• QMS Oversight & Review: Manage and review all Thane-related Change Controls, Incidents, Laboratory Investigations, Out of Specification (OOS), and Out of Trend (OOT) QMS documents to ensure absolute compliance and accuracy.
• Verification of Reference Documents: Perform a thorough review of supporting documents and raw data related to investigations to ensure the accuracy of all reference links.
• Cross-Functional Coordination: Maintain close coordination with Cross-Functional Teams (CFTs) to facilitate smooth execution, root cause analysis, and timely resolution of QMS-related activities.
• Timely Closure: Drive the completion and closure of all QMS activities within designated organizational timeframes.
• Trend Reporting: Compile and prepare metric-driven trend reports related to QMS activities for management review and continuous improvement.
• Calibration, Qualification & Laboratory Compliance
• Equipment Qualificat
📌 Senior Executive (Thane)
🏢 Rubicon Research
📍 Thane
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